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Perineal Ultrasound in Men Before and After Radical Prostatectomy

Primary Purpose

Urinary Incontinence, Stress

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Perineal Sonography
Sponsored by
Kantonsspital Winterthur KSW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Incontinence, Stress focused on measuring perineal sonography, male sling, post prostatectomy incontinence, ultrasonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male,
  • Elder than 18years
  • Planned RALP or history of RALP and PPSUI

Exclusion Criteria:

  • Patients with history of urinary incontinence before radical prostatectomy.
  • Patients with history of radiotherapy in the pelvis.
  • Other diseases involving pelvic floor.

Sites / Locations

  • Kantonsspital Winterthur

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

continent men after RALP

incontinent men after RALP

Arm Description

perineal sonography, questionnaires, 24h pad tests

perineal sonography, questionnaires, 24h pad tests

Outcomes

Primary Outcome Measures

perineal sonography
In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
IPSS (International Prostate Symptom Score)
score Points (numeric)
24h pad test
incontinence is measured by 24 pad test. pads are measured through scales.
perineal sonography
In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
IPSS (International Prostate Symptom Score)
score Points (numeric)
24h pad test
incontinence is measured by 24 pad test. pads are measured through scales.
perineal sonography
In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
IPSS (International Prostate Symptom Score)
score Points (numeric)
24h pad test
incontinence is measured by 24 pad test. pads are measured through scales.
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
score Points (numeric)
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
score Points (numeric)
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
score Points (numeric)
IIEF 5 (International Index of Erectile Function)
score Points (numeric)
IIEF 5 (International Index of Erectile Function)
score Points (numeric)
IIEF 5 (International Index of Erectile Function)
score Points (numeric)
VAS QoL (Visual Analogue Scale - Quality of Life)
score Points (numeric)
VAS QoL (Visual Analogue Scale - Quality of Life)
score Points (numeric)
VAS QoL (Visual Analogue Scale - Quality of Life)
score Points (numeric)
PGI (Patient Generated Index)
score Points (numeric)
PGI (Patient Generated Index)
score Points (numeric)
PGI (Patient Generated Index)
score Points (numeric)

Secondary Outcome Measures

Full Information

First Posted
August 2, 2016
Last Updated
April 23, 2020
Sponsor
Kantonsspital Winterthur KSW
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1. Study Identification

Unique Protocol Identification Number
NCT03037008
Brief Title
Perineal Ultrasound in Men Before and After Radical Prostatectomy
Official Title
Comparison of Perineal Ultrasound in Men Before and After Radical Prostatectomy and in Incontinent Men After Radical Prostatectomy Before and After Operative Treatment With Male Sling
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kantonsspital Winterthur KSW

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Prospective study to evaluate a new technique. Comparison of perineal sonography in men before and after radical prostatectomy and in incontinent men after radical prostatectomy before and after operative treatment with male sling and comparison with pre- and postoperative functional MRI Inclusion / Exclusion criteria: Inclusion: male, elder than 18years, planned RALP or history of RALP and PPSUI (Post Prostatectomy Stress Urinary Incontinence). Exclusion: Patients with history of urinary incontinence before radical prostatectomy. Patients with history of radiotherapy in the pelvis. Other diseases involving pelvic floor.
Detailed Description
After radical prostatectomy, a part of all patients suffer from urinary incontinence. Until now, only few information exists about the functional anatomy of the male pelvic floor, especially in incontinent men. Transperineal ultrasound is non-hazardous, cheap and easy available method to visualize the pelvic floor and is well established in gynecological examination. literature described the technique of transperineal ultrasound but there are no well established reference lines measured and the number of examined men in the series are small. The investigators want to confirm the published data and probably find new reference lines/parameters, e.g. the distance between the posterior wall of the symphysis to the posterior wall of the urethra in a direct, horizontal line. At the moment, the authors published data about urethral mobility, bladder neck opening and urethral angle. The investigators estimate that there is also a possible significant difference in the distance from the urethra to the symphysis in incontinent men compare to continent men after radical prostatectomy. Incontinent men can be treated by pelvic floor exercises or, in case of persisting incontinence, with operative treatment. There exists several techniques of implanted slings and meshes, similar to the better known TVT (tension free vaginal tape) in female urinary incontinence, besides the gold standard - the implantation of an artificial sphincter prosthesis. The sling-operations are less invasive, cheaper and preferred by patients du to the fact, that normal micturition is still possible. Nevertheless, around 20% of patients stay incontinent after sling operation. At the moment, it is unknown why they do not profit from the sling. In a previous study functional pelvic cine-MRI in patients with post-prostatectomy incontinence before and after implantation of a bulbourethral composite Suspension were compared. The investigators could find significant differences in the membranous urethral length and could show an elevation oft he bladder neck postoperatively but no significant MRI differences were found between patients showing clinical success or failure. With perineal sonography, the investigators want to establish a prediction tool for sling-operations in patients with urinary stress incontinence after radical prostatectomy. The purpose of this study is to evaluate whether perineal ultrasound in men is an adequate possibility to evaluate the pelvic floor and its function in the regard of urinary incontinence. The study is trying to find a prediction tool for bulbourethral composite suspension (sling-operation) using transperineal sonography. The investigators further want to establish and confirm parameters/standards to measure the male pelvic floor with the new technique of perineal sonography in men. Further the investigators want to to compare findings from perineal sonography with data from functional MRI in men with urinary incontinence following radical prostatectomy before and after bulbourethral composite suspension. Findings from perineal sonography with results from questionnaires concerning quality of life will be compared. There is a comparison study with two arms to compare the anatomy and function of the pelvic floor with perineal ultrasound from men prior to RALP due to prostate cancer, without prior history of diseases involving the pelvic floor. Participants will be asked to participate the study during routine consultations in the department of Kantonsspital Winterthur or selected in our database of the clinical information system searching for radical prostatectomies in the past and recruit these participants by telephone. In a modified lithotomy position (supine position with elevated legs), probands will get an examination of their pelvic floor by using a common ultrasound probe head on the perineum. During the examination, the bladder should be filled with around 300ml. If patient appear with empty bladder, the examination can be repeated on an other date. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. One examination takes around 30minutes. During ultrasound, the investigators want to illustrate the urethral mobility, the bladder neck opening and the urethral angle as well as the distance from the urethra to the symphysis. Urinary incontinence is measured by 24h pad test: Probands have to collect their pads, and scale them before and after using it during 24 hours, to measure the difference. The difference (after-before) shows the amount of lost urine. The results don't have to be exact and a result with a precision of approximately 50ml (= 50g) is acceptable. Results from urinary analysis (culture) are taken out of medical history from the hospitals database during the period of incontinence to exclude urinary tract infection. If no data is available, urinary analysis will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
perineal sonography, male sling, post prostatectomy incontinence, ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
continent men after RALP
Arm Type
Active Comparator
Arm Description
perineal sonography, questionnaires, 24h pad tests
Arm Title
incontinent men after RALP
Arm Type
Active Comparator
Arm Description
perineal sonography, questionnaires, 24h pad tests
Intervention Type
Device
Intervention Name(s)
Perineal Sonography
Other Intervention Name(s)
Perineal Ultrasound
Intervention Description
In a modified lithotomy position (supine position with elevated legs), probands will get an examination of their pelvic floor by using a common ultrasound probe head on the perineum. During the examination, the bladder should be filled with around 300ml. If patient appear with empty bladder, the examination can be repeated on an other date. During the examination, the pelvic floor will be observed during rest, coughing and valsalva-maneuver. One examination takes around 30minutes. During ultrasound, we want to illustrate the urethral mobility, the bladder neck opening and the urethral angle as well as the distance from the urethra to the symphysis.
Primary Outcome Measure Information:
Title
perineal sonography
Description
In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
Time Frame
1 - 4 weeks before RALP
Title
IPSS (International Prostate Symptom Score)
Description
score Points (numeric)
Time Frame
1 - 4 weeks before RALP
Title
24h pad test
Description
incontinence is measured by 24 pad test. pads are measured through scales.
Time Frame
1 - 4 weeks before RALP
Title
perineal sonography
Description
In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
Time Frame
6 weeks after RALP
Title
IPSS (International Prostate Symptom Score)
Description
score Points (numeric)
Time Frame
6 weeks after RALP
Title
24h pad test
Description
incontinence is measured by 24 pad test. pads are measured through scales.
Time Frame
6 weeks after RALP
Title
perineal sonography
Description
In a modified lithotomy position (supine position with elevated legs), probands get an examination of their pelvic floor by using a common ultrasound probe head on the Perineum. During the examination, the pelvic floor is observed during rest, coughing and valsalva-maneuver. Different Parameters (marked Points/anatomical structures) are measured.
Time Frame
6 months after RALP
Title
IPSS (International Prostate Symptom Score)
Description
score Points (numeric)
Time Frame
6 months after RALP
Title
24h pad test
Description
incontinence is measured by 24 pad test. pads are measured through scales.
Time Frame
6 months after RALP
Title
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
Description
score Points (numeric)
Time Frame
1 - 4 weeks before RALP
Title
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
Description
score Points (numeric)
Time Frame
6 weeks after RALP
Title
ICIQ SF (International Questionnaire on Urinary Incontinence - Short Form)
Description
score Points (numeric)
Time Frame
6 months after RALP
Title
IIEF 5 (International Index of Erectile Function)
Description
score Points (numeric)
Time Frame
1 - 4 weeks before RALP
Title
IIEF 5 (International Index of Erectile Function)
Description
score Points (numeric)
Time Frame
6 weeks after RALP
Title
IIEF 5 (International Index of Erectile Function)
Description
score Points (numeric)
Time Frame
6 months after RALP
Title
VAS QoL (Visual Analogue Scale - Quality of Life)
Description
score Points (numeric)
Time Frame
1 - 4 weeks before RALP
Title
VAS QoL (Visual Analogue Scale - Quality of Life)
Description
score Points (numeric)
Time Frame
6 weeks after RALP
Title
VAS QoL (Visual Analogue Scale - Quality of Life)
Description
score Points (numeric)
Time Frame
6 months after RALP
Title
PGI (Patient Generated Index)
Description
score Points (numeric)
Time Frame
1 - 4 weeks before RALP
Title
PGI (Patient Generated Index)
Description
score Points (numeric)
Time Frame
6 weeks after RALP
Title
PGI (Patient Generated Index)
Description
score Points (numeric)
Time Frame
6 months after RALP

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male, Elder than 18years Planned RALP or history of RALP and PPSUI Exclusion Criteria: Patients with history of urinary incontinence before radical prostatectomy. Patients with history of radiotherapy in the pelvis. Other diseases involving pelvic floor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert John, Prof.
Organizational Affiliation
Head of Kantonsspital Winterthur Urology
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Perineal Ultrasound in Men Before and After Radical Prostatectomy

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